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CSO A900, Instructions For Use Manual

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Z8A9F9 | IFU323EN00

 

 

INSTRUCTIONS FOR USE 

 

 

This document is the property of 

CSO Costruzione Strumenti Oftalmici srl. 

Any reproduction, even partial, it is prohibited.

 

3/60

 

1

 

INTRODUCTION 

The device is the result of a long research period, conducted by 

experts to give the product technical innovation, quality and design. 

The device can be easily used in ophthalmology to measure the intra-

ocular eye pressure. 

1.1

 

SYMBOLS 

Within the instructions for use, on the package or on the device, there 

can be the following symbols: 

Symbol 

Meaning 

 

Caution 

 

Read the instructions for use  

 

General mandatory action sign 

 

Note. Useful information for the user 

 

General prohibition sign 

 

Manufacturer 

 

CE Marking (Directive 93/42/EEC) Identification number of the 

notified body (IMQ) 

 

 

 

Summary of Contents for A900

Page 1: ...COSTRUZIONE STRUMENTI OFTALMICI 1 174 EN COSTRUZIONE STRUMENTI OFTALMICI phone 39 055 722191 fax 39 055 721557 cso csoitalia it www csoitalia it Z800 F900 A900 INSTRUCTIONS FOR USE APPLANATION TONOMETER ...

Page 2: ......

Page 3: ...NDITIONS 14 2 7 DISPOSAL AT THE END THE USEFUL LIFE 15 3 DEVICE DESCRIPTION 17 3 1 PROVISION DESCRIPTION 17 3 1 1 Tonometer Z800 20 3 1 2 Tonometer A900 21 3 1 3 Tonometer F900 22 3 2 TECHNICAL DATA 23 4 DEVICE USE 24 4 1 HOW TO INSTALL THE TONOMETER Z800 ON THE SLIT LAMP 24 4 2 HOW TO INSTALL THE TONOMETER A900 ON THE SLIT LAMP 25 4 3 HOW TO INSTALL THE TONOMETER F900 ON THE SLIT LAMP 27 4 4 HOW ...

Page 4: ...ONOMETER A900 FROM THE SLIT LAMP 42 4 16 HOW TO REMOVE THE TONOMETER F900 FROM THE SLIT LAMP 42 5 ORDINARY MAINTENANCE 43 5 1 SAFETY WARNINGS 43 5 2 DEVICE CLEANING 44 5 3 MEASURING PRISM CLEANING 45 5 3 1 Measuring prism disinfection 46 5 4 TONOMETER FUNCTIONING CHECK 49 5 4 1 Functioning check with measuring knob on 0 50 5 4 2 Functioning check with measuring knob on 2 52 5 4 3 Functioning check...

Page 5: ...echnical innovation quality and design The device can be easily used in ophthalmology to measure the intra ocular eye pressure 1 1 SYMBOLS Within the instructions for use on the package or on the device there can be the following symbols Symbol Meaning Caution Read the instructions for use General mandatory action sign Note Useful information for the user General prohibition sign Manufacturer CE M...

Page 6: ...ICES A900 AND F900 ARE ACCESSORIES COMPATIBLE WITH THE SLIT LAMP SL9900 Within the instructions for use the devices are identified by Z800 F900 or A900 When not specified the indications are applicable to all the devices THE ORIGINAL TEXT IS IN ITALIAN Before using the device or if you don t use it since a long time read these instructions carefully Read the instructions given in the instructions ...

Page 7: ...he Manufacturer reserves himself the right to modify the contents of the instructions for use without notice 1 3 NORMATIVE REFERENCES 1 3 1 COMMUNITY DIRECTIVES Directive 93 42 EEC and subsequent modifications and integrations concerning medical devices Directive 2008 98 EC on waste 1 3 2 TECHNICAL STANDARDS IEC 60601 1 2005 A1 2012 Medical electrical equipment Part 1 General requirements for basi...

Page 8: ...acturer electrical system of the space where the device is installed not in compliance with the technical standards the laws and regulations in effect in the country of installation of the device direct or indirect consequences or damages to objects or persons originating from the improper use of the device or erroneous clinical analysis originating from its use The Manufacturer guarantees the dev...

Page 9: ...maintenance carried out by personnel non authorized by the Manufacturer To ask maintenance interventions or to have technical information about the device address to an Authorized Service Center or directly to the device Manufacturer The client will not be refunded for damages originating from the device halt 1 5 MANUFACTURER IDENTIFICATION CSO S r l Costruzione Strumenti Oftalmici Via degli Stagn...

Page 10: ...e to verify if there are damage signs CAUTION Always keep the device out of the reach of children CAUTION Danger of device fall Check that the device is correctly fixed on the slit lamp Pay attention during the device assembly operations In case of accidental fall check the calibration and if necessary contact the Manufacturer CAUTION Before any measurement the contact surface of the measuring pri...

Page 11: ...indications on the cleaning and disinfection procedures refer to the paragraph Measuring prism disinfection at page 46 The only person responsible for not observing the cleaning and disinfection procedure is the user If you use a reusable measuring prism always disinfect it before carrying of the measurement on the patient s eye surface and immediately after the exam If you use a disposable measur...

Page 12: ... not recalled or described in the instructions for use It is forbidden to place the device in humid dusty places or environments subject to sudden temperature and humidity variations It is forbidden to use the device outdoors The measurement precision is influenced by corneal rigidity variations and changes The rigidity can be due to differences in the corneal thickness to intrinsic structural fac...

Page 13: ...ST CND national medical devices classification Repertoire number progressive system number attributed to the device Market release date The device registration data can be verified on the Ministero della Salute website on this page Ministero della Salute Ricerca dispositivi 2 2 2 DEVICE DATA PLATE Fig 1 Plate position tonometer Z800 Fig 2 Plate position tonometer A900 Fig 3 Plate position tonomete...

Page 14: ...he patient s risk of developing glaucoma The applanation tonometer functions according to the Goldmann method the measurement of the intraocular pressure is given by the required force to maintain a uniform applanation of the corneal surface The intraocular pressure measurement is conducted on the patient by means of the measuring prism in contact with the patient s cornea During the exam the meas...

Page 15: ... The tonometers have to be installed on the slit lamp by means of their support accessory The tonometers A900 and Z800 can be left on the slit lamp even when they are not in use and if necessary they can be placed in front of the microscope during the exam The CSO applanation tonometer is suitable for the majority of slit lamps from other suppliers 2 4 MEDICAL DEVICES CLASSIFICATION Technical data...

Page 16: ...ction against liquid infiltration Sterilization or disinfection method This device can be disinfected Protection degree in presence of anesthetics or inflammable detergents No protection Electrical connection degree between device and patient Appliances with part applied on the patient Use conditions Continuous functioning 2 6 ENVIRONMENTAL CONDITIONS Phase Technical data Min Max Transport Tempera...

Page 17: ...gative consequences for the environment and health caused by its improper disposal and lets the materials it is made of to be recycled so as to achieve a significant savings of energy and resources The user has to consider the effects potentially dangerous for the environment and the human health originating from an improper disposal of the whole device or its parts In case the user wishes to disp...

Page 18: ...se a used device put on the market after the 13th August 2005 the Distributor or the Manufacturer have to collect it the Manufacturer takes care by joining a consortium for the technological devices waste of the treatment and the recycling of the used device by paying its costs The Manufacturer is available to give the user all the information about the dangerous substances contained in the device...

Page 19: ...uzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 17 60 3 DEVICE DESCRIPTION 3 1 PROVISION DESCRIPTION Device Z800 Fig 7 Provision description Pos Denomination A Device B Hex key C Measuring prism D Functioning check accessory E Tonometer support optional ...

Page 20: ...is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 18 60 Device A900 Fig 8 Provision description Pos Denomination A Device B Measuring prism C Functioning check accessory D Tonometer support optional ...

Page 21: ...almici srl Any reproduction even partial it is prohibited 19 60 Device F900 Fig 9 Provision description Pos Denomination A Device B Measuring prism C Functioning check accessory D Tonometer support guide For the list of accessories and available models contact the Manufacturer or the local Distributor ...

Page 22: ...uzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 20 60 3 1 1 TONOMETER Z800 Fig 10 Tonometer Z800 Pos Description A Resting arm support B Tonometer Z800 body C Measuring scale knob D Arm E Measuring prism support F Functioning check accessory compartment ...

Page 23: ...talmici srl Any reproduction even partial it is prohibited 21 60 3 1 2 TONOMETER A900 Fig 11 Tonometer A900 Pos Description A Fixing connection for tonometer A900 B Connection support C Functioning check accessory compartment D Measuring scale knob E Measuring prism support F Arm G Tonometer A900 body ...

Page 24: ... Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 22 60 3 1 3 TONOMETER F900 Fig 12 Tonometer F900 Pos Description A Measuring prism support B Functioning check accessory compartment C Measuring scale knob D Support E Tonometer F900 body F Arm ...

Page 25: ...Pa Backlash width 0 49 mN Weight 0 85 kg without accessories Tonometer A900 Technical data Value Measuring force Generated through leverage weight Installation On the support pivot on top of the slit lamp microscope Measurement range Between 0 and 80 mmHg between 0 and 10 64 kPa Backlash width 0 49 mN Weight 0 82 kg without accessories Tonometer F900 Technical data Value Measuring force Generated ...

Page 26: ...oscope on its compartment Block it with the screw on the device 2 Place the tonometer on the support pivot Fig 13 How to place the tonometer support Fig 14 How to place the tonometer Z800 3 Free the arm fro the protection support and move it from the resting position to the measurement position 4 If necessary adjust the measuring prism support position to align it with the microscope shooting chan...

Page 27: ... position 4 2 HOW TO INSTALL THE TONOMETER A900 ON THE SLIT LAMP 1 Turn the lighting head of the slit lamp on the left or on the right oriented with a 90 angle 2 Place the tonometer support on top of the microscope on its compartment Block it with the screw on the device 3 Place the tonometer A900 connection support on the tonometer support Fig 17 How to place the tonometer support Fig 18 How to p...

Page 28: ...ne Strumenti Oftalmici srl Any reproduction even partial it is prohibited 26 60 4 Turn the tonometer and place the measuring prism in measurement position The blocking position ensures the correct position of the tonometer during the measurement Fig 19 Blocking position measurement rest ...

Page 29: ...eft or on the right oriented with a 90 angle 2 Remove the lid on the slit lamp arm and place the support in its seat 3 Place the tonometer F900 on the tonometer support guide Fig 20 How to place the tonometer support Fig 21 How to place the tonometer F900 4 On the support guide of the tonometer there are two holes that allow the correct tonometer positioning by aligning the measuring prism with th...

Page 30: ...ism semicircles can be observed and clearly focused during the measurement 1 Rotate the arm with measuring prism support on the observation axis of the microscope 2 Make sure that the oculars of the slit lamp are adjusted to compensate the operator s potential ametropia 3 Adjust the device light intensity 4 Inserting the blue filter in the slit lamp 5 Open the slit diaphragm completely The angle b...

Page 31: ...o obtain a clear image without reflection 4 6 HOW TO PREPARE THE SLIT LAMP F900 The microscope has to be adjusted so that the measuring prism semicircles can be observed and clearly focused during the measurement 1 Make sure that the oculars of the slit lamp are adjusted to compensate the operator s potential ametropia 2 Adjust the device light intensity 3 Inserting the blue filter in the slit lam...

Page 32: ...tact surface of the measuring prism must be inspected for contaminants or damage scratches cracks and sharp edges prior to every use Perform the check with a slit lamp microscope at 10 16 magnification Do not use the measuring prism beyond the date indicated indicated on the production batch written on the package or after two years from the date of first use During the measuring prism positioning...

Page 33: ...is not provided in disinfected conditions Never touch the prism from the part that will be in contact with the corneal surface 1 Make sure that the reusable measuring prism has been properly disinfected and stored in a sterile container 2 Carefully take the measuring prism Take the measuring prism from the sides Never touch the prism part that will be in contact with the corneal surface 3 Check th...

Page 34: ...sable prism after the exam 1 The disposable measuring prism has be new and sealed in its sterile package The package has to be intact 2 Carefully open the disposable measuring prism package Take the measuring prism from the sides Never touch the prism part that will be in contact with the corneal surface 3 Check the absence of damages on the measuring prism surface 4 Insert the measuring prism on ...

Page 35: ...2 Apply a local anesthetic drop on the eye surface to be examined 3 Apply sodium fluorescein 0 5 on the eye surface to be examined 4 Ask the patient to put the chin on the chin cup and the forehead against the forehead rest 5 Verify the correct eyes position respectively to the shooting channel 6 Ask the patient to look towards the front and keep the eyes open during the exam If necessary use the ...

Page 36: ...nt to open and close the eyes for a few seconds so that the tear film is evenly distributed on the corneal surface 2 Choose the blue filter to activate the fluorescein 3 Move forward the slit lamp until the measuring prism is into contact with the center of the cornea 4 Place the graduated scale on the value 1 5 Observing the applanated surface with the microscope you will see two semicircles of t...

Page 37: ...ments can be taken on any meridian In case of patients with astigmatism greater than 3 dioptres the choice of the prism position considering the flatter meridian is significant to improve the measurement accuracy The Goldmann tonometry to measure the real intra ocular pressure is based on the principle of applanation of a surface of 7 354 mm2 with 3 06 mm diameter from the center of the cornea The...

Page 38: ...e prism in correspondence to the average of the two meridians the flatter and steeper 4 11 CORRECTING THE WRONG ACQUISITIONS Observing the applanated surface with the microscope the two semicircles should be of the same size and perfectly aligned If the two semicircles are in a wrong position in what follows are described the possible causes and solutions to visualize the right position Fig 32 Rig...

Page 39: ...ring prism before positioning it again The image of the two semicircles is too small The intraocular pressure measurement might result lower than the real one Carefully clean the measuring prism before positioning it again The measuring prism does not touch the cornea or an excessive pressure has been applied Image Cause Solution If the patient draws his her head back slightly irregular movements ...

Page 40: ...he two semicircles are not visualized correctly Image Cause Solution Wrong the slit lamp position Adjust the slit lamp height and move it on the left with the joystick The semicircles are too far to the right Move the slit lamp on the right with the joystick The measurement might result way higher than the real one Adjust the slit lamp height Repeat the measurement ...

Page 41: ... two semicircles are centered but the sides are not correctly aligned Increase the pressure by turning the measurement knob The two semicircles are centered but the sides are not correctly aligned Increase the pressure by turning the measurement knob The two semicircles are centered but the sides are not correctly aligned Excessive applied pressure Reduce the pressure by rotating the measurement k...

Page 42: ...ng the measuring knob the pressure on the eye is increased until you obtain a continuous applanated and regular surface The intraocular pressure expressed in mmHg is calculated by multiplying the value indicated by the knob position times 10 In the following table is indicated the relationship between the measuring knob position the force and pressure in the applanated surface Position on the meas...

Page 43: ...0 4 13 HOW TO REMOVE THE MEASURING PRISM While removing the measuring prism use disposable gloves 1 Carefully remove the measuring prism from the support 2 If you used a reusable measuring prism clean it as described in the paragraph Measuring prism cleaning at page 45 3 If you use a disposable measuring prism dispose it immediately Fig 33 Measuring prism removal ...

Page 44: ...ve the support from the slit lamp 4 Keep the device in a dry and safe place 4 15 HOW TO REMOVE THE TONOMETER A900 FROM THE SLIT LAMP 1 Rotate the arm on the right The tonometer can be left on the slit lamp 2 Alternatively lift the tonometer too release it from the support pivot 3 Unscrew the screw and remove the support from the slit lamp 4 Keep the device in a dry and safe place 4 16 HOW TO REMOV...

Page 45: ...sinfection of the measuring prism described in this manual CAUTION Due to the large number of variables to be considered number of patients treatment type and concentration of the disinfectant used it is impossible to provide exact information on how long a measuring prism can be used Do not use the measuring prism beyond two years from the date written on the package in conformity with what is wr...

Page 46: ...suring prisms The cleaning procedure has to be carried out only reusable measuring prisms It is forbidden to use the following cleaning procedures They could damage the measuring prism Use of alcohol Use of acetone Use of UVA radiations Soaking the measuring prism in a fluid for more than 60 minutes Exposition to temperatures higher than 60 Different disinfection procedures than the one described ...

Page 47: ... seconds If necessary use a neutral pH detergent without irritating agents and a disposable cloth soft which does not release lint Always dab in the same direction 3 Rinse the measuring prism Make sure that there is no presence of detergent or contaminants It there is still some dirt repeat point 2 Fig 34 Measuring prism removal Fig 35 Measuring prism washing 4 Dry the measuring prism with a dispo...

Page 48: ...nfecting the measuring prism use disposable gloves 1 Fill a clean and disinfected container with the disinfectant solution The disinfectant solution shall cover the measuring prisms completely 2 Place the measuring prisms in the container 3 The measuring prisms shall not be on top of each other 4 The measuring prisms shall be completely immersed in the disinfectant solution 5 Let the disinfectant ...

Page 49: ...m in the container 6 After the indicated time has passed remove the measuring prisms from the container and let them drip for a few seconds 7 Place the measuring prism in another clean and disinfected container 8 Rinse the measuring prisms under running cold water for min 10 minutes max 15 minutes 9 Remove the measuring prisms from the container Fig 39 Rinsing the measuring prism in the container ...

Page 50: ... prisms in a hermetic and sterile container Fig 40 Drying the measuring prism Fig 41 Measuring prisms containers For the suitable disinfectants list for cleaning and disinfection of measuring prisms see the Report published by the American Academy of Ophthalmology at this page https www aaojournal org article S0161 6420 17 31677 9 pdf Disinfection of Tonometers a Report by the American Academy of ...

Page 51: ...o check the device correct functioning you need to use the specific functioning check accessory 1 Place the functioning check accessory on the device 2 The functioning check accessory has 5 markings on its body The markings correspond to the values indicated on the measuring knob 0 central 2 6 ends The functioning check accessory longer end shall be placed facing the examiner Fig 42 How to place t...

Page 52: ...IONING CHECK WITH MEASURING KNOB ON 0 1 Position the functioning check accessory in position 0 central and the measuring knob on the corresponding value 0 2 Turn the measuring knob on the value 0 05 measure equivalent to the width of the calibration sign on the measuring knob 3 The arm should be displaced in stop position facing the examiner 4 Turn the measuring knob on the value 0 05 measure equi...

Page 53: ...E This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 51 60 Fig 46 Tonometer A900 measuring knob Fig 47 Tonometer F900 measuring knob Fig 48 Tonometer Z800 measuring knob ...

Page 54: ...t This check should be carried out at least twice a year 1 Position the functioning check accessory in position 2 first lateral marking and the measuring knob on the corresponding value 2 2 Turn the measuring knob on the value 1 95 measure equivalent to the width of the calibration sign on the measuring knob 3 The arm should be displaced in stop position facing the examiner 4 Turn the measuring kn...

Page 55: ...E This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 53 60 Fig 51 Tonometer A900 measuring knob Fig 52 Tonometer F900 measuring knob Fig 53 Tonometer Z800 measuring knob ...

Page 56: ...g check accessory in position 6 second lateral marking and the measuring knob on the corresponding value 6 2 Turn the measuring knob on the value 5 95 measure equivalent to the width of the calibration sign on the measuring knob 3 The arm should be displaced in stop position facing the examiner 4 Turn the measuring knob on the value 6 05 measure equivalent to the width of the calibration sign on t...

Page 57: ...E This document is the property of CSO Costruzione Strumenti Oftalmici srl Any reproduction even partial it is prohibited 55 60 Fig 56 Tonometer A900 measuring knob Fig 57 Tonometer F900 measuring knob Fig 58 Tonometer Z800 measuring knob ...

Page 58: ...10200100 Applanation tonometer Z800 10200200 Applanation tonometer F900 10200220 Applanation tonometer A900 Support for tonometer F900 Code Description 100203112 Support for tonometer F900 Only for lamp SL9900 Support for tonometer A900 Code Description 100203100 Installation support for microscopes 2x 3x 5x galieian old version 100250303 Installation support for microscopes 2x 5x galieian and int...

Page 59: ...for microscopes 2x 3x 5x galieian old version 100203102 Installation support dominant left eye for microscopes 2x 3x 5x galieian old version 100250302 Installation support for microscopes 2x 5x galieian and internal zoom new version 100212608 Installation support on zoom microscopes Measuring prism Code Description 102001110 Reusable measuring prism for tonometer 102003200 Disposable sterile measu...

Page 60: ...ce in respect to the microscope The fastening screws of the tonometer are loosened Z800 Align the device with the microscope Fasten the device blocking screws with a suitable tool The device might have been hit If necessary contact the Technical Service for the device calibration Wrong horizontal alignment of the device in respect to the microscope The fastening screws of the tonometer are loosene...

Page 61: ... its seat The measuring prism could be bigger than the expected ones Adjust the blocking flaps on the measuring prism support so that it fits correctly Some measuring prisms could be bigger than the expected ones Use CSO spare parts only The measuring prism does not allow a clear visualization of the applanation Take the prism material is spoiled Replace the measuring prism with a new one Use CSO ...

Page 62: ...ned eye F900 Correctly place the tonometer in respect of the examined eye Read the indications given in the instructions for use The applanation is not correctly visualized during the measurement Missing fluorescein instillation in the examined eye Apply sodium fluorescein as indicated in the instructions for use Always use products compliant with the current legislation The applanation is not cor...

Page 63: ......

Page 64: ...COSTRUZIONE STRUMENTI OFTALMICI phone 39 055 722191 fax 39 055 721557 cso csoitalia it www csoitalia it 4 174 Z8A9F9 IFU323EN00 09 2018 ...

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